Aura Renew Acq Regulatory News (ARA)

9 Jan 2008 07:00

Ardana PLC09 January 2008 ARDANA ANNOUNCES OUTCOME OF PRE-IND MEETING WITH FDA ON TEVERELIX LA FOR THE TREATMENT OF ENDOMETRIOSIS Edinburgh, UK, January 9, 2008: Ardana Plc (LSE:ARA), the emergingpharmaceutical company specialising in improving human reproductive health,today announces the positive outcome of a pre-Investigational New Drug (IND)meeting with the United States Food and Drug Administration (FDA) for thedevelopment of its lead compound Teverelix LA (long-acting) for the treatment ofendometriosis. The pre-IND meeting resulted in agreement with the FDA on the clinicaldevelopment path for Teverelix LA in this indication. Ardana plans to open anIND in 2008 and submit the first Phase II study design shortly thereafter. Endometriosis arises in pre-menopausal women when the lining of the womb(endometrium) grows outside the uterus, typically in the pelvic cavity. Symptomsassociated with endometriosis include cyclical or chronic pelvic pain, heavyperiods and infertility. It is well documented that endometriosis is a hormonesensitive condition and a reduction in estrogen levels causes a shrinkage of theendometriotic lesions and an improvement in symptoms. Current treatment optionsinclude GnRH agonists however this class of compounds is associated with sideeffects similar to menopausal symptoms including hot flushes, reduced libido andloss of bone density, due to the reduction in estrogen levels to those seen inpost-menopausal women. In two previous Phase I clinical studies of different dose-regimens, TeverelixLA has been shown to reduce estrogen levels rapidly and in a dose-dependentmanner. Preliminary data from the second Phase I, randomised, single-blind,placebo-controlled study of a single subcutaneous injection of Teverelix LA, atone of two doses to 24 healthy female subjects, indicated that Teverelix LAcould reduce estrogen levels to a desired level at the lower end of the normalrange which should help to avoid menopausal symptoms. In this study estrogenlevels were reduced to average concentrations over a period of 8 weeks of 40.5pg/ml and 49.0 pg/ml respectively vs. 88.8 pg/ml for placebo. The effect of Teverelix LA on certain bone absorption markers such as serumtelopeptides and urine deoxypyridinoline were also investigated in this studyand these markers appeared to be unaffected by Teverelix LA. Commenting on today's announcement Dr Huw Jones, Ardana's CEO, said: "We areencouraged by the feedback we have received from the FDA on the way forward forTeverelix LA in endometriosis. There is, in our view, a high unmet medical needfor an effective treatment for endometriosis which does not produce menopausalsymptoms or a loss of bone mineral density." It has been estimated1 that 1 in 10 women suffer from some form of endometriosisduring their lives and in 2004 it was estimated that there were approximately 17million cases of endometriosis in the seven major pharmaceutical markets (US,Japan, France, Germany, Italy, Spain and the UK), of which approximately 3.9million cases were diagnosed. Teverelix LA is also being developed for the treatment of prostate cancer andBPH (benign prostatic hyperplasia) both of which currently have active INDs.Ardana announced positive Phase II data in both these indications in the secondhalf of 2007. 1 Source: Datamonitor July 2004 For more information contact: Ardana Financial DynamicsDr Huw Jones (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/Emma Thompson Tel: +44 (0)20 7831 3113 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development andmarketing of innovative products to improve human reproductive health, a $25.5billion market. Since its foundation, Ardana has built a broad and balanced portfolio to managerisk and actively pursues product and technology in-licensing and outlicensingto maintain a robust pipeline. Ardana's lead products are summarised below: • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-0705 a growth hormone secretagogue in Phase III for the diagnosis of growth hormone deficiency in adults • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase III trials; • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome, which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. In addition, Ardana has a strong portfolio of follow-on products in research.Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange